China NMPA Product Recall - ventilator systems

The National Medical Products Administration (NMPA) published an announcement on July 18, 2022, regarding a voluntary Level III recall initiated by MAQUET CRITICAL CARE AB, a medical device manufacturer. This recall, reported by MAQUET (Shanghai) Medical Equipment Co., Ltd., involves specific models and batches of ventilator systems. The primary issues leading to this action are the potential for users to accidentally step on the product's frame and the occurrence of multiple simultaneous ventilator alarms. These concerns highlight risks to both patient safety and device operational reliability. Under the NMPA's regulatory framework for medical device oversight, MAQUET CRITICAL CARE AB is undertaking a voluntary recall of the affected ventilator systems (Registration Certificate No.: 20213080373). The required action involves retrieving the impacted products to address these deficiencies. Comprehensive details regarding the specific models, specifications, and batches involved in this recall are available in the accompanying Medical Device Recall Event Report Form.